Accuracy of Computer Guided Four Implants Placement in Completely Edentulous Mandible

NCT ID: NCT06571968

Last Updated: 2025-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-14
• Study Completion Date: 2024-02-02

Brief Summary

Thirty-six completely edentulous healthy patients received four mandibular implants and were randomly divided into the following groups: (A) The implants were installed by fully guided stereolithographic stent (n = 18), and (B) The implants were installed by semi-guided stereolithographic stent. (n = 18). The accuracy analysis was performed by one experienced process engineer (DB). Cone beam computed tomography was performed before and after the surgical procedure to plan the virtual implant position and fabricate the surgical guide, as well as to determine implant position deviations. Both CBCT scans were superimposed, and the software compared preoperative linear and angular virtual measurements of planned implants with real measurements of the placed implants.

Detailed Description

Objectives: Current study aimed to assess the accuracy of fully- guided implant placement in completely lower edentulous patients compared to the semi-guided protocol.

Materials and Methods: Thirty-six completely edentulous healthy patients received four mandibular implants and were randomly divided into the following groups: (A) The implants were installed by fully guided stereolithographic stent (n = 18), and (B) The implants were installed by semi-guided stereolithographic stent. (n = 18). The accuracy analysis was performed by one experienced process engineer (DB). Cone beam computed tomography was performed before and after the surgical procedure to plan the virtual implant position and fabricate the surgical guide, as well as to determine implant position deviations. Both CBCT scans were superimposed, and the software compared preoperative linear and angular virtual measurements of planned implants with real measurements of the placed implants. Measurements and analysis of results were performed by means of a software tool used during virtual planning (P3Dental; Protótipos).

Conditions

Implant Placement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

fully guided surgical technique

The guides were designed with metal sleeves for guided drilling and guided implant placement and additional guide sleeves for the stabilization of the template by fixation screws.The implant width and length were selected for each patient according to previous 3d cone beam, and the drills of this kit were 11 mm longer than conventional drills. The surgery was performed without flap elevation. The guide was seated and fixed by means of 2-mm cortical screws in the buccal region after using of the corresponding drills.

Group Type: OTHER

fully guided stent

Intervention Type: DEVICE

All surgical procedures with drills were done through the stent., the implant was picked up from the implant holder and then installed, still with the surgical guide in situ, by using the ratchet and ratchet connector at a motor speed of 20 rpm, followed by cover screw placement without the need for sutures.

semi guided surgical technique

The guides were designed with metal sleeves for guided drilling and guided implant placement and additional guide sleeves for the stabilization of the template by fixation screws.The implant width and length were selected for each patient according to previous 3d cone beam, and the drills of this kit were 11 mm longer than conventional drills.The surgery was performed without flap elevation. The stent was removed before the final drilling

Group Type: OTHER

semiguided stent

Intervention Type: DEVICE

The first osteotomy was performed with the surgical guide in situ using a 1.95 mm pilot-drill. Successive color coded implant drills were used to prepare implant osteotomies. When using each twist drill, a removable sleeve having a diameter to coincide with the drill and inserted into the sleeve of the surgical guide.

The stereo lithographic guide template was removed and the receptor sites were irrigated with saline solution then the final drill of the implant system 3.5 mm diameter was used to finalize the osteotomy. The implant was gripped with the placement aid, released from the implant holder by 1/4 turn and manually inserted into the prepared implant site using a finger placement tool or hand ratchet. A torque of 45 N cm should not be exceeded during insertion procedure and cover screws were screwed over it.

Interventions

fully guided stent

All surgical procedures with drills were done through the stent., the implant was picked up from the implant holder and then installed, still with the surgical guide in situ, by using the ratchet and ratchet connector at a motor speed of 20 rpm, followed by cover screw placement without the need for sutures.

Intervention Type: DEVICE

semiguided stent

The first osteotomy was performed with the surgical guide in situ using a 1.95 mm pilot-drill. Successive color coded implant drills were used to prepare implant osteotomies. When using each twist drill, a removable sleeve having a diameter to coincide with the drill and inserted into the sleeve of the surgical guide.

The stereo lithographic guide template was removed and the receptor sites were irrigated with saline solution then the final drill of the implant system 3.5 mm diameter was used to finalize the osteotomy. The implant was gripped with the placement aid, released from the implant holder by 1/4 turn and manually inserted into the prepared implant site using a finger placement tool or hand ratchet. A torque of 45 N cm should not be exceeded during insertion procedure and cover screws were screwed over it.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• All patient wearing maxillary conventional denture.
• All patients had temporary mandibular overdenture supported by vertically inserted 4-implant at least six months ago.
• They were healthy, free from any systemic diseases relating to bone resorption such as uncontrolled diabetics or osteoporosis. This was achieved through medical history and clinical examination by physician.
• All patients are of angel's class I maxillo-mandibular relationships.

Exclusion Criteria

• Patients had head and neck radiotherapy, patients with bleeding disorders or hepatic patients.
• Patients with metabolic disorders as diabetes mellitus, osteoporosis and hepatic disorders that might affect osseointegration.
• Long term immunosuppress and corticosteroid drug therapy.
• Patient with abnormal habits as clenching and bruxism.
• Smoking patient.
• Patient with problems in TMJ

• Minimum Eligible Age: 58 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

marwa aboelez, Phd

Role: STUDY_CHAIR

Mansoura University

Hassan Kheriba, Msd

Role: STUDY_DIRECTOR

Mansoura University

Locations

Marwa Aboelez

Al Mansurah, , Egypt

Countries

Egypt

References

Malpartida-Carrillo V, Tinedo-Lopez PL, Ortiz-Culca F, Guerrero ME, Amaya-Pajares SP. Techniques for retrievability and for registering screw access holes in cement-retained implant-supported prostheses: A scoping review of the literature. J Prosthet Dent. 2020 Mar;123(3):427-433. doi: 10.1016/j.prosdent.2019.03.011. Epub 2019 Jul 12.

Reference Type: BACKGROUND

PMID: 31307803 (View on PubMed)

Other Identifiers

M05010322

Identifier Type: -

Identifier Source: org_study_id